DepressionNCT01817244
A Long Term Effect of Collaborative Care on Depression Treatment in a Community Dwelling Elderly
A study testing care management in people with Depression, run by National Clinical Research Coordination Center, Seoul, Korea at 1 site in South Korea.
Trial summary
Suicide is a significant cause of death in Korea. According to the report compiled by the Korea National Statistical Office, 24.8 victims of every 100,000 in 2007 (Korea National Statistical Office, 2008), which is higher compared with 10.1 in the United States, 6.0 in the United Kingdom, and 19.1 in Japan… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Depression
- What is being tested?
- care management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2013to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 60 and older
- current major or minor depression
Who cannot join
- severe cognitive dysfunction
- severe auditory dysfunction
- history of psychosis
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Kunkuk University of Chungju Hospital
Chungju, Choong-Book, 380700
About this study
Suicide is a significant cause of death in Korea. According to the report compiled by the Korea National Statistical Office, 24.8 victims of every 100,000 in 2007 (Korea National Statistical Office, 2008), which is higher compared with 10.1 in the United States, 6.0 in the United Kingdom, and 19.1 in Japan (Organisation for Economic Co-operation and Development, 2008). Especially, suicide rate is incredibly higher in elderly. Most persons who commit suicide have a diagnosed psychiatric disorder. Among them, 60% had Depression when they committed suicide. Therefore, this study aimed the impact of a care management intervention on depression treatment and reducing suicidal ideation in elderly patients with depression.
- Conditions
- Depression
- Being tested
- care management
- Keywords
- care management, depression, elderly, Korea
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
care managementOther
6-month care management
| Study group | Role | What they receive |
|---|---|---|
| care management type 1 | Experimental | 2-month care management Receives: Other: care management |
| care management type 2 | Active comparator | 6-month care management Receives: Other: care management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Scale (HAMD)
Measured: 6 months after baseline
Secondary outcomes (2)
suicide ideation
suicide ideation: suicide questionnaire
Measured: 6 months after baseline
treatment compliance
Measured: at 6 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Clinical Research Coordination Center, Seoul, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hyeon Woo Yim, National Clinical Research Coordination Center, Seoul, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01817244
- Sponsor's protocol ID
- A102065_2013
- Status last verified
- Jan 2017
- First submitted
- 13 Mar 2013
- Last updated
- 20 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long Term Effect of Collaborative Care on Depression Treatment in a Community Dwelling Elderly
- ClinicalTrials.gov ID
- NCT01817244
- Acronym / sponsor ID
- A102065_2013
- Conditions
- Depression
- Keywords
- care management, depression, elderly, Korea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- National Clinical Research Coordination Center, Seoul, KoreaOther government
- Study start
- Mar 2013 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 25 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Suicide is a significant cause of death in Korea. According to the report compiled by the Korea National Statistical Office, 24.8 victims of every 100,000 in 2007 (Korea National Statistical Office, 2008), which is higher compared with 10.1 in the United States, 6.0 in the United Kingdom, and 19.1 in Japan (Organisation for Economic Co-operation and Development, 2008). Especially, suicide rate is incredibly higher in elderly. Most persons who commit suicide have a diagnosed psychiatric disorder. Among them, 60% had Depression when they committed suicide. Therefore, this study aimed the impact of a care management intervention on depression treatment and reducing suicidal ideation in elderly patients with depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| care management type 1 | Experimental | Other: care management2-month care management |
| care management type 2 | Active comparator | Other: care management6-month care management |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 60 and older
- current major or minor depression
Key exclusion criteria (3 listed)
- severe cognitive dysfunction
- severe auditory dysfunction
- history of psychosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| care management6-month care management | Other | care management type 1, care management type 2 |
Primary outcome
Hamilton Depression Scale (HAMD)
Time frame: 6 months after baseline
2 secondary outcomes
suicide ideation
Time frame: 6 months after baseline
treatment compliance
Time frame: at 6 months from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2017.
Related trials for Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing care management in people with Depression, run by National Clinical Research Coordination Center, Seoul, Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Depression Scale (HAMD) (time frame: 6 months after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2017.